Lifestyle Heart Trial

Phase 2

Completed

• Conditions: Coronary Disease; Hypercholesterolemia; Coronary Arteriosclerosis; Heart Diseases; Hypertension; Myocardial Ischemia; Cardiovascular Diseases

• Registration Number: NCT00000471
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

To assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis.

Detailed Description

BACKGROUND:

The trial was the first randomized, controlled trial to determine whether patients outside a hospital could be motivated to make and sustain comprehensive lifestyle changes and whether coronary disease regression could occur as a result of lifestyle changes alone.

DESIGN NARRATIVE:

Patients were randomly assigned to an experimental group or to a usual-care group. Experimental-group patients were prescribed a lifestyle program including a low-fat vegetarian diet, moderate aerobic exercise, stress management training, stopping smoking, and group support. No animal products were allowed in the vegetarian diet except egg white and one cup per day of non-fat milk or yogurt. The diet contained approximately 10 percent of calories as fat. Control-group patients were not asked to make lifestyle changes. Coronary angiography was performed at baseline and at one year to assess progression or regression of disease. Patients were recruited into the trial between January 1986 and November 1988. The trial was supported prior to April 1989 from various sources other than the National Heart, Lung, and Blood Institute. Follow-up continued for four years.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Study Timeline

• Study Start: 1989-04
• Study Completion: 1993-03
• Study First Submitted: 1999-10-27
• Study First Submitted QC: 1999-10-27
• Study First Posted: 1999-10-28
• Status Verified: 2000-01
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified